# K151739: Revision Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Nov 23, 2015 after 150 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921308 (1994). 38 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092331: Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;, Encore Medical L.P. (2010) Summary page 5.
- K992667: ZMR Hip System-Revision Taper, Zimmer, Inc. (1999) Summary page 5.
- K031572: ZMR Hip System-XL, Models 9921, 9922 and 9923, Zimmer, Inc. (2003) Summary page 5.

## Most influential descendants
- K170690: M-Vizion Femoral Revision System (2017), 5 descendants of its own
- K191816: M-Vizion Femoral Revision System Extension (2020), 4 descendants of its own
- K201471: M-Vizion Femoral Revision System Extension (2021), 3 descendants of its own
- K212327: M-Vizion Monobloc (2022), 1 descendant of its own
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own

## Indications for use
Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

Source page: https://510kreport.com/device/K151739
Methodology: https://510kreport.com/methodology